Environmentally hazardous substances (aquatic environment)
Environmentally hazardous substances include, inter alia, liquid or solid substances pollutant to the aquatic environment and solutions and mixtures of such substances (such as preparations and wastes).
For the purposes of 18.104.22.168.10, "substance" means chemical elements and their compounds inthe natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurities deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
The aquatic environment may be considered in terms of the aquatic organisms that live in the water, and the aquatic ecosystem of which they are part9. The basis, therefore, of the identification of hazard is the aquatic toxicity of the substance or mixture, although this may be modified by further information on the degradation and bioaccumulation behaviour.
While the following classification procedure is intended to apply to all substances and mixtures, it is recognised that in some cases, e.g. metals or poorly soluble inorganic compounds, special guidance will be necessary10.
The following definitions apply for acronyms or terms used in this section:
-BCF: Bioconcentration Factor;-BOD: Biochemical Oxygen Demand;
-COD: Chemical Oxygen Demand;
-GLP: Good Laboratory Practices;
-ECx: the concentration associated with x% response;
-EC50: the effective concentration of substance that causes 50% of the maximum response;
-ErC50: EC50in terms of reduction of growth;
9 This does not address aquatic pollutants for which there may be a need to consider effects beyond the aquatic environment such as the impacts on human health etc.
10 This can be found in Annex 10 of the GHS.
-Kow: octanol/water partition coefficient;
-LC50(50% lethal concentration): the concentration of a substance in water which causes thedeath of 50% (one half) in a group of test animals;
-L(E)C50: LC50or EC50;
-NOEC (No Observed Effect Concentration): the test concentration immediately below the lowesttested concentration with statistically significant adverse effect. The NOEC has no statisticallysignificant adverse effect compared to the control;
-OECD Test Guidelines: Test guidelines published by the Organization for EconomicCooperation and Development (OECD).
The basic elements for classification of environmentally hazardous substances (aquatic environment) are:
(a)Acute aquatic toxicity;
(b)Chronic aquatic toxicity;
(c)Potential for or actual bioaccumulation;and
(d)Degradation (biotic or abiotic) for organic chemicals.
While data from internationally harmonised test methods are preferred, in practice, data from national methods may also be used where they are considered as equivalent. In general, it has been agreed that freshwater and marine species toxicity data can be considered as equivalent data and are preferably to be derived using OECD Test Guidelines or equivalent according to the principles of Good Laboratory Practices (GLP). Where such data are not available, classification shall be based on the best available data.
Acute aquatic toxicitymeans the intrinsic property of a substance to be injurious to an organism in a short-term aquatic exposure to that substance.
Acute (short-term) hazard,for classification purposes,means the hazard of a chemical caused by its acute toxicity to an organism during short-term aquatic exposure to that chemical.
Acute aquatic toxicity shall normally be determined using a fish 96 hour LC50(OECD TestGuideline 203 or equivalent), a crustacea species 48 hour EC50(OECDTest Guideline 202 or equivalent) and/or an algal species 72 or 96 hour EC50(OECD Test Guideline 201 or equivalent).These species are considered as surrogate for all aquatic organisms and data on other species such as Lemna may also be considered if thetest methodology is suitable.
Chronic aquatic toxicitymeans the intrinsic property of a substance to cause adverse effects to aquatic organisms during aquatic exposures which are determined in relation to the life-cycle of the organism.
Long-term hazard, for classification purposes, means the hazard of a chemical caused by its chronic toxicity following long-term exposure in the aquatic environment.
Chronic toxicity data are less available than acute data and the range of testing procedures less standardised. Data generated according to the OECD Test Guidelines 210 (Fish Early Life Stage) or 211 (Daphnia Reproduction) and 201 (Algal Growth Inhibition) may be accepted. Other validated and internationally accepted tests may also be used. The NOECs or other equivalent ECxshall be used.
Bioaccumulationmeans net result of uptake, transformation and elimination of a substance in an organism due to all routes of exposure (i.e. air, water, sediment/soil and food).
The potential for bioaccumulation shall normally be determined by using the octanol/water partition coefficient, usually reported as a log Kowdetermined according to OECD Test Guideline 107 or 117. While this represents a potential to bioaccumulate, an experimentally determined Bioconcentration Factor (BCF) provides a better measure and shall be used in preference when available. A BCF shall be determined according to OECD Test Guideline 107, 117 or 123.
Degradationmeans the decomposition of organic molecules to smaller molecules and eventually to carbon dioxide, water and salts.
Environmental degradation may be biotic or abiotic (e.g. hydrolysis) and the criteria used reflect this fact. Ready biodegradation is most easily defined using the biodegradability tests (A-F) of OECD Test Guideline 301. A pass level in these tests may be considered as indicative of rapid degradation in most environments. These are freshwater tests and thus the use of the results from OECD Test Guideline 306, which is more suitable for marine environments, has also been included.Where such data are not available, a BOD(5days)/COD ratio≥ 0.5 is considered as indicative of rapid degradation.
Abiotic degradation such as hydrolysis, primary degradation, both abiotic and biotic, degradation in non-aquatic media and proven rapid degradation in the environment may all be considered in defining rapid degradability11.
Substances are considered rapidly degradable in the environment if the following criteria are met:
(a)In 28-day ready biodegradation studies, the following levels of degradation are achieved:
(i)Tests based on dissolved organic carbon: 70%;
(ii)Tests based on oxygen depletion or carbon dioxide generation: 60% of theoreticalmaxima;
These levels of biodegradation shall be achieved within 10 days of the start of degradation which point is taken as the time when 10% of the substance has been degraded", unless the substance is identified as a complex, multi-component substance with structurally similarconstituents. In this case, and where there is sufficient justification, the 10-day window condition may be waived and the pass level applied at 28 days12; or
(b)In those cases where only BOD and COD data are available, when the ratio of BOD5/COD is ≥ 0.5; or
(c)If other convincing scientific evidence is available to demonstrate that the substance can bedegraded (biotically and/or abiotically) in the aquatic environment to a level above 70% withina 28 day period.